Title: What the new AAPS White Paper recommends for immunogenicity assays supporting biosimilars
Duration: 1 hour
The demonstration of similar immunogenicity is a critical requirement for the demonstration of similarity between a biosimilar candidate and the respective reference product. While recent progress has been made in describing and understanding the challenges of the assessment of anti-drug antibodies (ADAs) in support of biosimilar programs in the clinical setting, lack of specific guidance on development and validation requirements for immunogenicity assessments of biosimilars and reference biologics in comparability studies has led to the use of different approaches in different programs.
This presentation will discuss what the new AAPS White Paper, co-authored with the FDA and EMA, recommends for the development and validation of immunogenicity assays in support of biosimilar programs. It will also explore what it recommends for the use of a single, biosimilar-based assay for assessing immunogenic similarity in support of biosimilar drug development.
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